Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 5x100mm
LUTONIX, INC.
BSCLX35755100
In Commercial Distribution

  • 00801741098529 ()

  • Balloon Diameter, 5mm
  • Catheter Length, 75cm
  • Balloon Length, 100mm
BSCLX35755100

  • Peripheral angioplasty balloon catheter, drug-coated
The Gas Sampling Line (p/n 90031) delivers a gas sample of the ventilator gas flow to the monitoring system in the LungFit PH. The gas sampling line has a male Luer lock connector at each end that is attached at one end to the inspiratory limb of the ventilator breathing circuit via the sample T adaptor (with a female Luer lock connector), near the patient connection and to the LungFit PH System female Leur Lock connector gas sampling port at the other end. The gas sample line is composed of a 12 inch length of Nafion tubing for removing moisture from the sample gas, a gas sample tube with Leur fittings and a hydrophobic filter to prevent any remaining water in the sample gas from entering the LungFit PH.
Beyond Air, Inc.
90031
In Commercial Distribution

  • B882900310 ()
  • B882900311 ()
  • B882900312 ()


  • Nitric oxide delivery unit, system-based
No Description
Oscor Inc.
664760-302
In Commercial Distribution

  • 20802526563229 ()
  • 00802526563225 ()
LS21-10

  • Endocardial defibrillation lead
TUBING SET CEDTTS100 5PK US
MEDTRONIC, INC.
CEDTTS100
In Commercial Distribution

  • 00763000709181 ()
  • 20763000709185 ()


  • Cardiac ablation system irrigation tubing set
Integrated Bipolar Pace/Sense and Defibrillation Lead
BOSTON SCIENTIFIC CORPORATION
640263-103
In Commercial Distribution

  • 00802526601835 ()

  • 64 cm Length
640263-103

  • Endocardial defibrillation lead
Integrated Bipolar Pace/Sense and Defibrillation Lead
BOSTON SCIENTIFIC CORPORATION
640262-103
In Commercial Distribution

  • 00802526601828 ()

  • 59 cm Length
640262-103

  • Endocardial defibrillation lead
Integrated Bipolar Pace/Sense and Defibrillation Lead
BOSTON SCIENTIFIC CORPORATION
640273-103
In Commercial Distribution

  • 00802526601811 ()

  • 64 cm Length
640273-103

  • Endocardial defibrillation lead
Integrated Bipolar Pace/Sense and Defibrillation Lead
BOSTON SCIENTIFIC CORPORATION
640272-103
In Commercial Distribution

  • 00802526601804 ()

  • 59 cm Length
640272-103

  • Endocardial defibrillation lead
Subcutaneous Electrode
BOSTON SCIENTIFIC CORPORATION
3501
In Commercial Distribution

  • 00802526599200 ()

  • 45 cm Length


  • Endocardial defibrillation lead
Steroid-eluting Bipolar Pace/Sense and Defibrillation Lead
BOSTON SCIENTIFIC CORPORATION
0651
In Commercial Distribution

  • 00802526592874 ()

  • 70 cm Length


  • Endocardial defibrillation lead
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